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Completed

NCT Number: NCT05847543

Building an AI to Infer/Predict an Estimated Stool Microbiome Profile

This is a study to collect data to build, evaluate and validate (test) a tool to infer/predict an estimated microbiome (community of microorganisms such as bacteria, fungi and viruses that exists in a particular environment) profile. The study will take place at several hospitals/clinics across Singapore, Malaysia, and Thailand.

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Key information

Conditions

Healthy

Age range

0 month–18 month

Sex eligibility

All sexes

Study type

Observational

Primary location

University Malaya Medical Center, Kuala Lumpur, Malaysia

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children aged from 0 to 18 months old
  • Parent(s) should have access to the internet and a smartphone or tablet to upload stool data and complete the study questionnaires in the OneBiome web-platform.
  • Parent(s) should be able to comprehend the content of the study and to complete the study procedures in English.
  • Written consent from parent.

Exclusion criteria

  • Parent(s) incapable of completing the study questionnaires and uploading of the stool data using smart phone or tablet with internet.
  • Children born before gestational age 37 weeks.
  • Any other family member is enrolled in the study
  • Incapability of parents of children to comply with study protocol or Investigator's uncertainty about the willingness or ability of the parents of children to comply with the protocol requirements.

Treatment and study plan

Stool diaper data and sample collection

Other

Stool diaper data and sample collection

Primary outcomes

  1. To collect stool data and stool samples for full microbiome analysis. To collect stool images, stool data and stool samples for full microbiome analysis

    Time frame: 7 days

    To collect stool data and stool samples for full microbiome analysis.

    To collect stool images, stool data and stool samples for full microbiome analysis

Secondary outcomes

  1. To assess the microbiome composition in the stool sample of the subject

    Time frame: 7 days

    To assess the microbiome composition in the stool sample of the subject

  2. To assess the dietary pattern based on Food Frequency Questionnaire (FFQ)

    Time frame: 7 days

    To determine/assess the eating/dietary pattern of the participants based on the Food Frequency Questionnaire (FFQ) data and reflect insights in the OneBiome report

  3. To explore the association between microbiome composition and known factors that influence the microbiome in early life

    Time frame: 7 days

    To explore the association between microbiome composition and known factors that influence the microbiome in early life including mode of delivery, antibiotic prophylaxis, infant feeding patterns and diet

Other outcomes

  1. The accuracy level of the stool AI in predicting the stool consistency using BITSS versus the scores provided by parents

    Time frame: 7 days

    The accuracy level of the stool AI in predicting the stool consistency using BITSS 4-point scale versus the scores provided by parents on the same 4-point scale

Sponsors and collaborators

Lead sponsor

Danone Asia Pacific Holdings Pte, Ltd.

Industry

Collaborators

  • KK Women's and Children's Hospital
  • Mount Elizabeth Medical Centre
  • National University Hospital, Singapore
  • Thammasat University Hospital
  • University of Malaya

Registry information

Official study title

A Study to Develop, Evaluate, and Validate a Tool to Infer/Predict an Estimated Microbiome Profile

Acronym: Poobiome

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 6, 2023
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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